Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May - 03 Jul 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no positive control data mentioned in study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no positive control data mentioned in study report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted in 1996, prior to adoption of LLNA method in 2002.
Test material
- Reference substance name:
- Fatty acids C16-18 (even numbered), oligoesters with sucrose
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Fatty acids C16-18 (even numbered), oligoesters with sucrose
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Remarks:
- HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Borchen, Germany
- Microbiological status of animals, when known: SPF breeding colony
- Weight at study initiation: 345 - 420 g
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: Commercial diet, (ssniff Ms-H(V2233), ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 17 May - 21 Jun 1996
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.3 mL sesame oil
- Remarks:
- used to moisten the test substance
- Concentration / amount:
- 100%
- Day(s)/duration:
- On each of days 1, 8, and 15 for 6-hour exposure duration
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.3 mL sesame oil
- Remarks:
- used to moisten the test substance
- Concentration / amount:
- 100%
- Day(s)/duration:
- On day 29, 6-hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 negative control
20 test animals - Details on study design:
- RANGE FINDING TESTS:
Six animals were used for determination of non-irritant concentration: 4% and 20% in sesame oil, and 100% moistened with 0.3 mL sesame oil was applied topically to two guinea pigs per concentration. The hair on the left flank of the animals was removed mechanically. An amount of 0.5 g of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was fixed to the left flank and covered occlusively for 6 hours with a bandage and film. After 24 hours following removal of the patches, the treated skin areas were examined for erythema and oedema according to the score of Draize.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: During Day 1-15 topical exposure was done once a week.
- Test groups: 20 animals
- Control group: 10 animals
- Site: Left flank: 0.5 mL of the test substance was applied over a 2 x 2 cm patch. Control animals were treated with analogously with sesame oil.
- Frequency of applications: once a week
- Duration: 6 hour exposure under occlusive bandage
- Concentrations: 100% moistened with 0.3 mL sesame oil
After induction exposure the occlusive bandage was removed and the skin washed with warm water. Clinical signs and irritant effects were recorded.
B. CHALLENGE EXPOSURE
The hair of the previously untreated right flank was removed mechanically.
- No. of exposures: 1
- Day(s) of challenge: Day 29
- Exposure period: 6 hour exposure under occlusive bandage
- Test groups: 20 animals
- Control group: 10 animals
- Site: Hind part of right flank: 0.5 g of the test substance preparation was applied over a patch. Vehicle alone was applied to the front part of right flank.
- Concentrations: 100% moistened with 0.3 mL sesame oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches.
After removal of the occlusive bandage, any remnants of the substance were carefully washed off with warm water. - Positive control substance(s):
- not specified
- Remarks:
- no positive control data mentioned in study report
Results and discussion
- Positive control results:
- No positive control used.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none, no erythema, no oedema
- Group:
- positive control
- Remarks on result:
- other: no positive control data mentioned in study report
Any other information on results incl. tables
Range finding test: As no signs of irritation occurred after application of the different test concentrations, 100 % was selected for challenge application.
The body weight gains of the animals were not impaired.
The animals of the treatment and control group showed no signs of skin irritation during induction phase.
No signs of irritation (no erythema and no oedema) were observed in the control and the treatment group 24 and 48 hours after removal of challenge patches.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
